I know people say the law is confusing but most experts I've talked to and my reading of the law - says companies can't make profit off RTT...https://twitter.com/GideonGil/status/1009539155167236098 …
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Replying to @SarahKarlin
how are they defining "profit" though? like, a single dollar over the cost of manufacturing? or can companies factor in development costs?
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Replying to @damiangarde @SarahKarlin
The problem is - I am told, I’m not a lawyer - is, if a company says, well $150,000 is our cost, we r not making a profit, there’s no entity charged with confirming that. Under expanded access, the confirmation of cost would be done by the FDA. So, who will keep companies honest?
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There's no entity charged w confirming the price is only direct costs beforehand. But I think FDA can check that after the fact. The law functions as an exemption to usual FDA reqs. If parameters of law-including for charging-aren't met, FDA reqs apply.
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Replying to @pzettler @ABatemanHouse and
And I'd personally love to know the company's rationale for concluding it can charge a profit under RTT, should, say, any reporter wants to ask them!
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Replying to @pzettler @ABatemanHouse and
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@pzettler, your thoughts? Blowing smoke?https://www.prnewswire.com/news-releases/beacon-capitals-investments-validated-by-the-passing-of-the-right-to-try-bill-for-experimental-drugs-300668353.html …1 reply 0 retweets 1 like -
Replying to @SteveJoffe @ABatemanHouse and
They don't seem to be a sponsor - they seem to be creating a matching service? If that's true, seems to me like they'll have quite a bit of room for profit. (They do seem a bit confused tho - e.g., RTT does not cover devices.) Curious what others think!
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Replying to @pzettler @ABatemanHouse and
I have been worried that scoundrels will set up
#RightToTry mills. They won't make the products themselves, but will peddle hope and charge up the wazoo for their services in trying to get pts access--without much concern for medical appropriateness or patients' best interests.3 replies 1 retweet 4 likes -
Replying to @SteveJoffe @ABatemanHouse and
Hell, Dr Burzinski might be considering franchising right now...
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Replying to @300ZXNA @SteveJoffe and
Yep. The minute the law passed,
@gorskon said, well Burzynski’s business model is now legal....1 reply 0 retweets 1 like
And it is. Burzynski was using the Texas #RightToTry before the federal version passed, but what he was doing could still be sanctioned by the @US_FDA. No more.
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